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Nano-Pulse Stimulation (NPS) in Sebaceous Hyperplasia

Primary Purpose

Skin Lesion, Skin Abnormalities, Sebaceous Hyperplasia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Nano-Pulse Stimulation Device

About this trial

This is an interventional treatment trial for Skin Lesion focused on measuring Nano-Pulse Stimulation, NPS

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Males or females
Presents with at least 2 and up to 5 clinically visible SH lesions
Understands that 1 lesion will remain untreated to act as a reference
Lesions must measure no greater than 2.5 x 2.5 at the outside margin
Wishes to have at least 1 and perhaps 2 NPS treatments to each study lesion
Selection of the non-treated reference lesion will be randomly identified
Willing to return for 4 or 5 total study visits at specified intervals over 60 or 90 days
Agrees to photographic or other image capture methods of both the treated and untreated lesions.
Agrees to avoid any other treatment to the NPS treated and untreated SH lesions until the end of the NPS study
Has no evidence of active infection in the designated tissue prior to treatment and reports no infection within 90 days
Is not allergic to Lidocaine or Lidocaine-like products

Exclusion Criteria:

Presence of Implantable electronic devices that cannot be removed. e.g., pacemaker or automatic defibrillator
Taking medications prescribed for cardiac arrhythmia at any time within 6 months prior to exposure to the NPS device
SH lesions are located within the eye orbit or on the nose
Active infection or history of infection in designated test area within 90 days prior to study initiation
Use of oral steroid and/or retinoid use within the last 12 months
Prior treatment to the identified SH lesions targeted for the study which occurred within 6 months prior to study start
Is known to be immune-compromised and/or received immunosuppressant therapy within 6 months prior to study start
Taking blood thinning medications
Has Insulin dependent diabetes
Is known to be pregnant or lactating female

Sites / Locations

Laser & Skin Surgery Medical Group, Inc.
Premier Plastic Surgery
Skin Care Physicians
Zel Skin & Laser Specialists
Dermatology, Laser & Vein Specialists of the Carolinas, PLLC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NPS Treated SH Lesion

Arm Description

Nano-Pulse Stimulation Device using pre-defined energy protocol

Outcomes

Primary Outcome Measures

Lesion Clearance

At least 50% of the NPS treated lesions will be rated as "CLEAR" or "MOSTLY CLEAR"

Secondary Outcome Measures

Full Information

NCT ID

NCT03612570

First Posted

July 27, 2018

Last Updated

February 17, 2019

Sponsor

Pulse Biosciences, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03612570

Brief Title

Nano-Pulse Stimulation (NPS) in Sebaceous Hyperplasia

Official Title

Evaluation of Nano-Pulse Stimulation (NPS) in Sebaceous Hyperplasia

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

July 10, 2018 (Actual)

Primary Completion Date

November 28, 2018 (Actual)

Study Completion Date

December 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pulse Biosciences, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

This prospective, open label, muti-center study evaluates the use of Nano-Pulse Stimulation (NPS) in the treatment of Sebaceous Hyperplasia (SH) lesions less than 2.5mm in size.

Detailed Description

The study is designed with each subject serving as his or her own control. A total of up to 75 subjects with 2-5 qualifying SH lesions will be enrolled and treated with either a 1.5-mm x 1.5-mm or 2.5-mm x 2.5-mm tip. One lesion will be randomized as a untreated control and no NPS energy will be delivered. All treated lesions will receive at least one NPS treatment and evaluated at 30 days for lesion clearance. Initial lesions scored as Not Clear or Partially Clear may undergo a second NPS treatment. All subjects will have their lesions evaluated at 60 days post-primary or secondary treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Skin Lesion, Skin Abnormalities, Sebaceous Hyperplasia

Keywords

Nano-Pulse Stimulation, NPS

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

72 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NPS Treated SH Lesion

Arm Type

Experimental

Arm Description

Nano-Pulse Stimulation Device using pre-defined energy protocol

Intervention Type

Device

Intervention Name(s)

Nano-Pulse Stimulation Device

Intervention Description

NPS utilizes a timed series of low energy, high voltage nanosecond (billionth of a second) pulses which are applied directly to targeted tissue using small microneedles. NPS energy induces cell signaling and the activation of cellular pathways by creating transient nanopores in cellular membranes and organelles and initiate regulated cell death.

Primary Outcome Measure Information:

Title

Lesion Clearance

Description

At least 50% of the NPS treated lesions will be rated as "CLEAR" or "MOSTLY CLEAR"

Time Frame

60-day Follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Males or females Presents with at least 2 and up to 5 clinically visible SH lesions Understands that 1 lesion will remain untreated to act as a reference Lesions must measure no greater than 2.5 x 2.5 at the outside margin Wishes to have at least 1 and perhaps 2 NPS treatments to each study lesion Selection of the non-treated reference lesion will be randomly identified Willing to return for 4 or 5 total study visits at specified intervals over 60 or 90 days Agrees to photographic or other image capture methods of both the treated and untreated lesions. Agrees to avoid any other treatment to the NPS treated and untreated SH lesions until the end of the NPS study Has no evidence of active infection in the designated tissue prior to treatment and reports no infection within 90 days Is not allergic to Lidocaine or Lidocaine-like products Exclusion Criteria: Presence of Implantable electronic devices that cannot be removed. e.g., pacemaker or automatic defibrillator Taking medications prescribed for cardiac arrhythmia at any time within 6 months prior to exposure to the NPS device SH lesions are located within the eye orbit or on the nose Active infection or history of infection in designated test area within 90 days prior to study initiation Use of oral steroid and/or retinoid use within the last 12 months Prior treatment to the identified SH lesions targeted for the study which occurred within 6 months prior to study start Is known to be immune-compromised and/or received immunosuppressant therapy within 6 months prior to study start Taking blood thinning medications Has Insulin dependent diabetes Is known to be pregnant or lactating female

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard Nuccitelli, PhD

Organizational Affiliation

Pulse Biosciences, Inc.

Official's Role

Study Chair

Facility Information:

Facility Name

Laser & Skin Surgery Medical Group, Inc.

City

Sacramento

State/Province

California

ZIP/Postal Code

95816

Country

United States

Facility Name

Premier Plastic Surgery

City

San Mateo

State/Province

California

ZIP/Postal Code

94401

Country

United States

Facility Name

Skin Care Physicians

City

Chestnut Hill

State/Province

Massachusetts

ZIP/Postal Code

02467

Country

United States

Facility Name

Zel Skin & Laser Specialists

City

Edina

State/Province

Minnesota

ZIP/Postal Code

55424

Country

United States

Facility Name

Dermatology, Laser & Vein Specialists of the Carolinas, PLLC

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28207

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31592824

Citation

Munavalli GS, Zelickson BD, Selim MM, Kilmer SL, Rohrer TE, Newman J, Jauregui L, Knape WA, Ebbers E, Uecker D, Nuccitelli R. Safety and Efficacy of Nanosecond Pulsed Electric Field Treatment of Sebaceous Gland Hyperplasia. Dermatol Surg. 2020 Jun;46(6):803-809. doi: 10.1097/DSS.0000000000002154.

Results Reference

derived

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Nano-Pulse Stimulation (NPS) in Sebaceous Hyperplasia

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